Comments invited on the ICH E2C (R2) guideline on periodic benefit-risk evaluation report

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16/04/2012

Comments invited on the ICH E2C (R2) guideline on periodic benefit-risk evaluation report

The European Medicines Agency is inviting comments on the recently published ICH E2C (R2) guideline on periodic benefit-risk evaluation report (PBRER) from its stakeholders. The guideline reached step 2 of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) process in February 2012 and now enters step 3, the consultation period. 

The focus of the current 'ICH E2C (R1) guideline on periodic safety update report (PSUR) for marketed drugs' is on relevant new safety information in the context of patient exposure, to determine if changes are needed to the medicine information in order to optimise the use of the medicine. The pharmacovigilance environment has evolved, however, prompting reassessment of the role of the PSUR in the spectrum of safety documents submitted to regulatory authorities. 

With recognition that the assessment of the risk of a medicine is most meaningful when considered in light of its benefits, the proposed revised guideline on PBRER provides greater emphasis on benefit, particularly when risk estimates change significantly. In such cases there will need to be an overall explicit evaluation of benefit-risk. Consequently the name of the proposed report is the 'periodic benefit-risk evaluation report'.

The PBRER would also provide greater emphasis on the cumulative knowledge regarding a medicine, while retaining a focus on new information.

Stakeholders are asked to provide comments using this template. The comments template should be sent to ich@ema.europa.eu.

The deadline for comments is 21 May 2012. 

Related information

Contact point:

ich@ema.europa.eu